BS ISO 19227:2018 specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process.

This document does not specify requirements for packaging or sterilization which are covered by other International Standards.

This document applies to in-process cleaning and final cleaning.

This document does not apply to liquid or gaseous implants.

This document does not apply to cleaning processes performed by the user or under the responsibility of the user.


Cross References:
ISO 10993-1
ASTM D7066-04
ISO 10993-5
ISO 11737-1
ISO 9377-2
NF S94-091
ISO 10993-12
ASTM F3127
ISO 3951-2
IMDRF SG3/N99-10:2004
AAMI ST72
ISO 14971
EN 13018
ISO 3951-1
EN 1484
ASTM F2459
ISO 10993-17
ISO 14644
ISO 2859-1
ISO/IEC 17025
ISO 13485
ICH Q3D
AAMI TIR42:2010


All current amendments available at time of purchase are included with the purchase of this document.